A Multi-Site Evaluation of the Pain Relief, Support, Fit and Comfort From Use of a Custom Knee or Ankle Brace in Persons Suffering From Chronic Ankle or Knee Pain and Instability

Joint Instability Clinical Trial

Official title:

A Multi-Site Evaluation of the Pain Relief, Support, Fit and Comfort From Use of a Custom Knee or Ankle Brace in Persons Suffering From Chronic Ankle or Knee Pain and Instability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02682654
• Other study ID #: 18325
• Status: Completed
• Phase: N/A
• Start date: February 5, 2016
• Est. completion date: April 26, 2016

Study information

• Verified date: December 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will look to examine the overall performance of a custom fit knee or ankle brace as a means of providing ankle or knee joint support in subjects that have determined the need for bracing based upon chronic joint instability and/or joint swelling and pain following daily activity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: April 26, 2016
• Est. primary completion date: April 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subjects must indicate that they currently have weakened ankles or knees and that they experience chronic discomfort after performing daily activities.

• Subjects must suffer from pain assessed on a 100 mm (10 cm) Visual Analog Scale (VAS) of =20 mm to = 90 mm for subjects with either unstable ankle or unstable knee, at Visit 1 and 2.

• Subjects must be able to walk unaided by cane or walker.

• Subjects must not have a noticeable limp or other permanent ailment that interferes with normal gait.

• Subjects free of other types of health problems that, in the opinion of the Investigator, could influence their ability to participate.

• If subjects are taking pain medication (prescription or Over-the-counter (OTC)) for a chronic condition, they may continue that medication as long as they have been on a stable dose for at least 2 months, and agree to continue their regular dose and regimen for the duration of the study.

• Subjects must be willing to undergo a 1-week period without a brace and then willing to wear a brace for a 1-week period, that is: 8 ±2 hours a day for a minimum of 5 out of 7 days.

Exclusion Criteria:

• Subjects with an ankle or knee pain and instability which is due to a recent sprains, strains, or other non-reversible injury to the knee or ankle.

• Subjects who have diabetes, circulatory problems, open wounds, and lack of sensation in the ankles, knees, or feet or any problems that would make brace wear uncomfortable or inappropriate.

• Subjects who wear a physician-prescribed orthotic device, prescription shoes or back braces.

• Subjects who are undergoing traction or manipulative back adjustments or have had a traumatic injury to the lower extremity (deemed of non-overuse nature), which in the opinion of the examining Investigator would interfere with the study evaluations.

• Subjects whose condition requires surgery or other medical intervention or who have undergone foot back or knee surgery within the past 3 months or with any planned surgeries and/or invasive medical procedures during the course of the study.

• Subjects who are currently taking an opioid based pain medication or have taken such medication within 2 months prior to Visit 1.

• Subjects who are taking any chronic pain medication (prescription or OTC) for at least 2 months, who do not agree to continue taking it at the same dose and regimen throughout the study.

• Subjects who have severely painful bunions, warts, corns and/or calluses, severely overlapping toes or lesions on the bottom of their foot.

• Subjects who have sensitivities or allergies to plastics or adhesives.

Related Conditions & MeSH terms

• Joint Instability

Intervention

Device:
• Dr. Scholl's Prototype Ankle Brace
Subjects will be instructed to wear the assigned Ankle/Knee brace for 8 ± 2 hours per day, for a minimun of 5 days out of a 7-day/1 week wear period.
• Dr. Scholl's Prototype Knee Brace
Subjects will be instructed to wear the assigned Ankle/Knee brace for 8 ± 2 hours per day, for a minimun of 5 days out of a 7-day/1 week wear period.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comfort	Comfort is assessed utilizing a 7-point Comfort/Discomfort Likert scale.	Up to 15 days
Primary	Pain Relief of Knee or Ankle joint	Evaluation of Knee or Ankle joint pain will be performed using the Visual Analog Scale utilizing a 100 mm line defined at each end of the line by 0 = no pain and 100 = Worst pain possible.	Up to 15 days
Secondary	Product Fit	Product Fit is assessed utilizing a 7-point scale.	Up to 15 days
Secondary	Product Support	Support is assessed utilizing a 5-point scale.	Up to 15 days
Secondary	Freedom of Movement	Freedom of Movement is assessed utilizing a 6-point scale.	Up to 15 days
Secondary	Subjective Questions	Applicable subjective questions will be assessed utilizing the subjective questionnaire.	Up to 15 days

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